Study on the Effects of Muscadine Grape Extract in Men Undergoing Hormone Therapy for Prostate Cancer

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03496805

Provider View

This clinical trial is exploring whether adding muscadine grape extract to standard hormone therapy can help improve symptoms in men with prostate cancer. The study focuses on reducing fatigue and improving quality of life.

Patient Parameters

Program Overview

This study aims to find out if taking muscadine grape extract (MGE) along with hormone therapy can help men with prostate cancer feel less tired and improve their overall well-being. Muscadine grapes are known for their health benefits, including anti-inflammatory and antioxidant properties. Researchers are interested in seeing if these benefits can help men undergoing androgen deprivation therapy (ADT) for prostate cancer.

Description

The main goal of this study is to see if men taking muscadine grape extract (MGE) feel less tired after six months compared to those taking a placebo. Researchers will also look at fatigue levels at 3, 9, and 12 months, as well as quality of life, physical fitness, and how the cancer progresses.

Participants will be randomly assigned to one of two groups:

  • Group I (Muscadine Grape Extract): Participants will start hormone therapy and then take muscadine grape extract by mouth twice a day for 12 months, as long as their cancer does not worsen or they do not experience severe side effects.

  • Group II (Placebo): Participants will start hormone therapy and then take a placebo by mouth twice a day for 12 months, under the same conditions as Group I.

After finishing the treatment, participants will have follow-up visits at 72 hours and then for up to 12 months to monitor their health and any changes in their condition.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older who speak English.
  • Diagnosed with prostate cancer.
  • Currently receiving hormone therapy or have had surgical castration, with plans to continue hormone therapy for the next 12 months.
  • Normal blood and organ function based on recent lab tests.
  • Able to walk, even with assistance.
  • Willing to participate in study activities and follow instructions.
  • Agree to use effective birth control during the study.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Have painful cancer spread that needs medical treatment.
  • Had prostate cancer surgery or radiation in the last 60 days.
  • Rising PSA levels while on current prostate cancer treatment.
  • Planning to stop hormone therapy or start chemotherapy within 12 months.
  • Using other experimental cancer treatments.
  • Allergic to similar compounds as MGE.
  • Cannot swallow pills.
  • Have digestive issues causing severe diarrhea or nausea.
  • Have uncontrolled health problems like infections, heart issues, or mental health conditions that would interfere with the study.

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